Abstract
Simple and rapid spectrophotometric method for the quantitative analysis of Pitavastatin calcium (PTV) in raw material and tablets pharmaceutical formulation has been described. The method is based on the formation of yellow ion-pair complex between Pitavastatin calcium and Bromocresol purple (BCP) in chloroform medium. Different parameters affecting the reaction such as: effect of solvents, stability, reagent concentration, correlation ratio, etc. were optimized. The formed complex was quantified spectrophotometrically at absorption maximum 405 nm. Linearity range was 2.20 - 35.23 µg/mL, regression analysis showed a good correlation coefficient R2 = 0.9991. The limit of detection (LOD) and limit of quantification (LOQ) were to be 0.367 µg/mL and 1.112 µg/mL respectively. The average percent recovery was found to be (100.62 – 101.14) % for Pitavastatin Calcium. This study was applied on Syrian pharmaceutical trademark: (PAVACRIUM 4 & Londalop). The method was successfully applied for the determination of Pitavastatin calcium in tablets pharmaceutical formulation. The proposed method is simple, direct, sensitive and do not require any extraction process. Thus, this method could be readily applicable for the quality control and routine analysis.
Highlights
Pitavastatin is the first synthetic 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor which was discovered in Japan
The concentration of the (BCP) reagent changes within the ratio (0.25 × 10-4 – 7.0 × 10-5) M while the concentration of Pitavastatin calcium was constant in each solution and equal to 2.5 × 10-5 M
We studied the linearity of Pitavastatin calcium concentrations at the optimal conditions, where we made a series of 10 mL of separated volumetric flasks, each one contains concentration of Bromocresol purple (BCP) equals to ten times of Pitavastatin calcium concentration, where the variable concentrations of PTV stock solution 1 ×10-3 M and the concentrations of BCP stock solution 1 ×10-2 M, the volumetric flasks completed to 10 mL with Chloroform, we measured the absorbance at 405 nm for each concentration against the blank of BCP in chloroform
Summary
Pitavastatin is the first synthetic 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor which was discovered in Japan. It is chemically monocalcium bis (3R,5S,6E)-7-(2-cyclopropyl-4-[4-fluorophenyl]-3quinolyl-3,5-dihydroxy-6-heptenoate), used as the calcium salt in the treatment of hyperlipidaemia and can reduce the risk of cardiovascular diseases in everyday medical practice. Based on the preclinical findings, Pitavastatin significantly decreased the serum levels of total cholesterol and low-density lipoprotein cholesterol at doses of 1 mg/day or more. The estimation of Pitavastatin calcium (PTV) from pharmaceutical formulations has been determining by several analytical methods. Ultra High performance liquid chromatography (UHPLC) method for the selective quantification of Pitavastatin calcium[17]. Liquid chromatography-tandem mass spectrometry (LC-MS/MS)21,22 , Bromocresol purple (BCP) which is a brominated acid dye of the sulfonephthalein series derived from orthocresol that is obtained as a pinkish crystalline powder and is used as an acid-base indicator commonly used as indicator and spectrophotometric reagent
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